Skip to content

Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier

Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06371235
Acronym
Pregiferon
Enrollment
250
Registered
2024-04-17
Start date
2024-09-30
Completion date
2027-03-31
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons

Brief summary

The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy.

Interventions

OTHERPregiferon

This Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier

Sponsors

CerbaXpert
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant woman over 18 years old * Woman whose gestational age is less than 30 weeks. * Having agreed to carry out an assay of anti-IFN alpha IgG auto-Ac before 30 weeks * Give birth in the inclusion center * Suffering from a pathology frequently associated with the presence of these anti-autoantibodies IFN alpha (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, auto-thyroid disease immune system such as Graves' disease, Hashimoto's thyroiditis) or knowing its positive anti-IFN alpha autoantibody status * Affiliated with the Social Security system

Exclusion criteria

* Patient who underwent a blood transfusion less than 2 months ago * Patient who received an organ transplant * Patient undergoing immunotherapy, stem cell therapy and/or other malignancy maternal, under heavy treatment (chemotherapy) less than 6 months before inclusion

Design outcomes

Primary

MeasureTime frameDescription
Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn.30 monthsA placental transfer will be defined by the presence of anti-IFN alpha IgG auto Ab in the blood. of the umbilical cord. The transfer frequency will be calculated with its overall 95% confidence interval and by pathology (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, autoimmune thyroid disease such such as Graves' disease, Hashimoto's thyroiditis), in HIV-positive women by pathology (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, autoimmune thyroid disease such as Graves' disease, Hashimoto's thyroiditis), in HIV-positive women.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026